Regulating Chemicals

The 2006 installment of GlobalChem, the chemical industry's annual conference on chemical regulation, gave plenty of attention to the new international agreement for managing commercial substances. But speakers at the conference in Baltimore on March 28-29 sent a mixed message on that deal, the Strategic Approach to International Chemicals Management (SAICM).

The global chemical industry has generally supported SAICM, which offers voluntary guidelines for making, transporting, using, and disposing of chemicals in ways that protect people's health and the environment. Nonetheless, the industry, like environmental groups and others, is not totally satisfied with the outcome of the agreement, completed in February in Dubai, United Arab Emirates (C&EN, Feb. 27, page 31).

Conference keynote speaker Angela Logomasini depicted SAICM as a tool for the European Union to spread its planned regulatory system for the Registration, Evaluation & Authorization of Chemicals (REACH) to other parts of the world. Many in the U.S. chemical industry strongly oppose REACH, viewing it as an overly burdensome regulatory system that will hurt European industry and impede exports of U.S. products to the EU.

SAICM is a way to globalize REACH, argued Logomasini, director of risk and environmental policy at the Competitive Enterprise Institute, a think tank that advances free enterprise and limited government. "This is not simply about promoting the trade in chemicals," she said of SAICM.

Logomasini said the goals of the chemicals management accord "could be done in a private market. I don't know why we need government institutions" involved.

Though SAICM is voluntary, its effect will be that national governments, notably those in developing countries, will be moved to enact new laws controlling chemicals, she said. Plus, the chemicals management strategy put forth in SAICM will help expand existing international environmental treaties and possibly support the creation of new ones, which would be legally binding on participating countries, Logomasini said.

Meanwhile, Ernest S. Rosenberg, president and chief executive officer of the U.S. Soap & Detergent Association, predicted that the biggest impact that SAICM will have on U.S. chemical makers is "deselection." Deselection is a decision by downstream industrial users, retailers, consumers, or institutional buyers to stop using a particular product or chemical, he explained. It can follow the listing of a substance as hazardous or attacks on a chemical or product by activist groups, Rosenberg added.

SAICM also potentially provides the United Nations Environment Program a "bully pulpit" to criticize countries that already have well-developed chemical management programs and not just developing countries that lack regulations, Rosenberg said.

SAICM "gives the appearance of global consensus on approaches to chemical management that are still highly controversial," he continued. A "global action plan" that accompanies SAICM lists scores of activities for chemicals management, but details in that document were not fully hashed out by negotiators, Rosenberg pointed out. Those management activities are wide-ranging and include developing better methods to determine the impact of chemicals on human health and eliminating child labor that involves hazardous substances.

He also agreed with Logomasini, saying the EU "is aggressively pursuing ... the export of REACH through SAICM."

Jack Gerard, president and CEO of the American Chemistry Council (ACC), offered a different take. SAICM will provide a risk- and science-based approach to the management of chemicals, he told the conference.

"Thanks to the great work of our industry, Responsible Care will play an important part" in SAICM implementation worldwide, Gerard said. The International Council of Chemical Associations, which includes ACC, announced in February its new Responsible Care Global Charter and a Global Product Strategy in conjunction with the completion of the global chemicals management strategy. The charter and strategy include guidelines for product stewardship and the sharing of best chemical management strategies within the chemical industry and with its customers.

SAICM was one of a number of international and domestic regulatory initiatives related to assessing chemical hazards discussed at GlobalChem, which was hosted by ACC and the Synthetic Organic Chemical Manufacturers Association.

Linda Gerber, acting associate director of the Environmental Protection Agency's Chemical Control Division, described international efforts toward development of a harmonized system that will allow a company to submit a single notification before commercializing a new chemical in two or more industrialized countries. The notifications give regulators a first look at a new compound to see if it might have any impacts on health or the environment.

Currently, chemical makers must send a notification to the government of each nation in which they plan to market a new substance. The project to streamline this process, called "mutual acceptance of notification," is an endeavor of the Organization for Economic Cooperation & Development (OECD), a bloc of 30 of the world's most industrialized countries.

The first step toward achieving mutual acceptance of new chemical notification involves agreement on assessment of hazards, such as chemical toxicity, Gerber said. The OECD New Chemicals Task Force has a pilot project to increase mutual understanding and acceptance of new chemical hazard assessments among the organization's member governments.

Currently, Australia, Canada, Japan, and the U.S. are involved in the review of five substances in this pilot effort. "We found we're a lot more alike than different" in approaches to hazard assessment, she said.

The next stages of the OECD process may focus on mutual acceptance of data about a chemical's use, production volume, and potential exposure, Gerber said.

Charles M. Auer, director of EPA's Office of Pollution Prevention & Toxics, said OECD governments are spending much time and effort on this pilot project. He urged chemical manufacturers to join this effort to bring mutual acceptance of notification to fruition. "Enthusiastic support [by] industry is necessary," he told the conference. Without significant business participation, "it's not going happen."

Auer pointed out, too, that mutual acceptance of new chemical notification among OECD countries is part of SAICM implementation.

Nanomaterial regulation by EPA was also a hot topic among participants at the conference. The agency is working to develop assessment tools specific to nanomaterials as part of its reviews of new chemical substances, said James B. Willis, director of EPA's Chemical Control Division. Reviews of "traditional" new chemicals rely heavily on a molecule's structure-activity relationship, but these data do not help in EPA's assessments of nanomaterials, he pointed out.

The agency has received about 17 premanufacture notices for nanomaterials, each of which met the traditional definition of a "new chemical" under the Toxic Substances Control Act, Willis said. In addition to its standard data requirements for new compounds, EPA is finding that it needs other information for nanomaterials. This includes a description of the substance's crystal structure, particle weight, shape and surface area, and aggregation or agglomeration characteristics, as well as information about the substance's novel properties.

Nanomaterials may be made with existing chemicals and have unique or enhanced properties that could trigger an agency review of them as new substances. Willis said EPA is working on a document that will describe how the agency plans to distinguish between nanomaterials that will be considered new chemicals and those deemed to be existing substances. The agency hopes to release that document by this summer, he added.

EPA is also working internationally on how best to review the potential impacts of new nanomaterials. OECD has established a working party on the health and environmental safety implications of intentionally manufactured nanomaterials, Willis said. This group wants to ensure that testing guidelines for and regulatory review of nanomaterials will be consistent among OECD countries, he said.

Meanwhile, Canadian officials at the conference described their work reviewing commercial chemicals. Environment Canada and Health Canada are required by law to determine, in a process called categorization, which of the 23,000 chemicals in domestic commerce there should undergo assessment for possible regulation.

Canada is the first country to do a systematic review of all commercial chemicals in its domestic market, said Mary Ellen Perkin, head of the industrial information unit for existing substances at Environment Canada. The agencies are to finish categorizing commercial chemicals by Sept. 14.

Chemicals pegged for detailed assessments will be those posing the greatest potential for human exposure or those that are toxic and either persistent or bioaccumulative, Perkin said. So far, the two agencies have identified about 1,000 chemicals as their highest priority for further investigation. About 400 substances are toxic, persistent, and bioaccumulative, Perkin said. Another 350 or so are persistent, toxic, and used or manufactured in high volumes in Canada, she said. And some 260 chemicals have high potential for exposure and are hazardous to humans. These substances will undergo a screening assessment, then, if deemed necessary, an in-depth assessment.

Through a reporting survey issued on March 4, Environment Canada is collecting information on about 500 chemicals. These materials were selected because they are hazardous to human health or the environment, have potential for affecting human health, or are "substances of emerging concern and international interest," according to Perkin.

In the survey, Canadian companies that manufactured or imported more than 100 kg of any of the substances in 2005 must provide data including how much of each of the chemicals they made or shipped into the country. Many of the listed compounds may no longer be on the market in Canada, according to a notice announcing the survey, which is available at www.ec.gc.ca/Ceparegistry/documents/notices/g1-14009_n1.pdf.

Perkin urged U.S. chemical companies to check over the list of substances covered by the survey and to alert their Canadian customers if products they export contain any of the listed substances.